FDA: Page 20
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Sarah Silbiger via Getty Images
FDA panel to review once-rejected Acadia drug for psychosis
The biotech company is making another attempt at expanding Nuplazid's use after an unexpected regulatory setback last year.
By Kristin Jensen • March 10, 2022 -
Permission granted by Bristol-Myers Squibb
In first, Bristol Myers wins FDA OK for Opdivo use before surgery in lung cancer
Opdivo's approval is another step in drugmaker efforts to establish immunotherapy drugs earlier in cancer treatment.
By Ben Fidler • March 7, 2022 -
Sarah Silbiger via Getty Images
FDA sets back Karyopharm's bid to broaden use of cancer drug
The biotech appeared poised to seek approval of its treatment, selinexor, in endometrial cancer. But regulators had a "differing" view of the data and requested another clinical trial.
By Kristin Jensen • March 2, 2022 -
Mario Tama via Getty Images
J&J, Legend cell therapy approved by FDA for multiple myeloma
The CAR-T treatment is the second to be approved in the U.S. for the blood cancer, following Bristol Myers Squibb and 2Seventy bio's Abecma.
By Ned Pagliarulo • Updated March 1, 2022 -
Sarah Silbiger via Getty Images
FDA rejects Reata drug for rare kidney disease
While expected, the decision raises questions about the treatment's prospects in other settings. Reata may have better luck with another drug it's submitting to the FDA for a movement disorder.
By Jonathan Gardner • Feb. 28, 2022 -
DNY59 via Getty Images
Lilly, Boehringer diabetes pill wins expanded use in heart failure
The FDA OK greatly broadens the number of patients eligible for Jardiance, which first won approval in 2014 as a treatment for low blood sugar in people with diabetes.
By Jonathan Gardner • Feb. 25, 2022 -
Warren Little via Getty Images
Citing safety signal, GSK pauses some trials of new RSV vaccine
As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.
By Jonathan Gardner • Feb. 18, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets FDA decision date for earlier use of CAR-T therapy
The FDA will decide whether to approve Bristol Myers' Breyanzi for second-line lymphoma treatment by late June, two months after it's set to make a similar decision for Gilead's Yescarta.
By Ned Pagliarulo • Feb. 17, 2022 -
Win McNamee via Getty Images
Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency
Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.
By Jonathan Gardner • Updated Feb. 15, 2022 -
Courtesy of Pfizer
FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift
The FDA pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting that was scheduled for this week has been postponed as a result.
By Ben Fidler • Feb. 11, 2022 -
Sarah Silbiger via Getty Images
FDA sends signal with tough questions of Lilly at cancer drug meeting
The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.
By Jonathan Gardner • Feb. 10, 2022 -
Sarah Silbiger via Getty Images
Why the FDA is making a test case of a cancer drug from China
The FDA appears unlikely to approve an immunotherapy developed by Eli Lilly and China's Innovent Biologics, citing issues with their trial data. A rejection, however, could shut out lower-cost competition.
By Ben Fidler , Jonathan Gardner • Updated Feb. 10, 2022 -
Courtesy of Sanofi
Sanofi's Bioverativ deal begins to pay dividends with first new drug approval
The FDA's clearance of Enjaymo for cold agglutinin disease means Sanofi has a new marketed product to show for its 2018 buyout of Biogen's former spinoff.
By Jonathan Gardner • Feb. 7, 2022 -
Courtesy of Eli Lilly
Lilly slows FDA submission of Alzheimer's drug after Medicare decision
Executives for the pharma downplayed the impact of an accelerated approval for donanemab, pointing to Medicare's plans to restrict coverage of Alzheimer's drugs like it to only patients in clinical trials.
By Jonathan Gardner • Feb. 3, 2022 -
Sarah Silbiger via Getty Images
First generic of top-selling eye drug Restasis approved by FDA
At least nine generic drugmakers have tried to win approval of a lower-cost competitor to AbbVie's medicine, which has enjoyed market dominance for nearly two decades. Viatris is the first to succeed.
By Kristin Jensen • Feb. 3, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids
The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5 years of age continues.
By Kristin Jensen • Feb. 2, 2022 -
Roche wins FDA approval for rival to Regeneron's lucrative eye drug
The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants.
By Jonathan Gardner • Jan. 31, 2022 -
Courtesy of Regeneron Pharmaceuticals
Regeneron, Sanofi are latest to withdraw a cancer drug application
The partners pulled their request after disagreeing with the FDA on post-approval studies for their immunotherapy Libtayo in cervical cancer. Incyte made a similar decision earlier this week.
By Jonathan Gardner • Jan. 28, 2022 -
Sarah Silbiger via Getty Images
A biotech wins the first FDA drug approval in a rare type of eye cancer
U.K.-based Immunocore's treatment, known as Kimmtrak, is also the first T cell receptor drug to have reached market in the U.S. so far.
By Jonathan Gardner • Jan. 26, 2022 -
Sarah Silbiger via Getty Images
Incyte withdraws cancer drug from FDA review after discussions with regulator
The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals.
By Kristin Jensen • Jan. 26, 2022 -
Justin Sullivan via Getty Images
Gilead's oncology plans take a hit as FDA stops tests of key cancer drug
U.S. regulators halted several studies of a drug Gilead paid almost $5 billion to acquire in 2020 after researchers observed an "apparent imbalance" of serious adverse reactions.
By Ben Fidler • Jan. 26, 2022 -
Permission granted by Gilead Sciences
US turns to Gilead's COVID-19 drug to help counter omicron
With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.
By Ben Fidler • Jan. 24, 2022 -
FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi
AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.
By Jacob Bell • Jan. 18, 2022 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 questions facing the FDA in 2022
If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.
By Jonathan Gardner • Jan. 11, 2022 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA approval decisions to watch in the first quarter
The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug, as well as mark the start of a price battle in oncology.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • Updated March 1, 2022
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